ITRM940730A1 - DYNAMIC PROSTHESIS IN DOUBLE LAYER FOR SURGICAL TREATMENT OF INGUINAL HERNIA - Google Patents

Abstract

PCT No. PCT/IT95/00179 Sec. 371 Date Jul. 8, 1996 Sec. 102(e) Date Jul. 8, 1996 PCT Filed Nov. 7, 1995 PCT Pub. No. WO96/14805 PCT Pub. Date May 23, 1996The present invention relates to a double layer prothesis that is applied to every patient suffering from inguinal hernia. The two lower and upper layers of this dynamic prosthesis can move independently one from the other, since each of said two layers is fixed only on a side facing the side of the other layer. All this avoids, during muscular movements, (deambulation, cough efforts and so on), the formation of some traction and/or torsion points, frequently responsible for immediate post-operative and/or long term troubles and pains. The lower layer creates a new internal inguinal orifice and exercises a "sling" action on the spermatic cord. Said cord takes a "S" shape crossing the double prosthetic layer. The combination of the "sling" with the "S" shape of the cord prevents relapsing external oblique hernias.

Description

DESCRIPTION OF THE INDUSTRIAL INVENTION HAVING THE TITLE: "DYNAMIC PROSTHESIS IN DOUBLE LAYER FOR THE SURGICAL TREATMENT OF THE INGUINAL HERNIA"

SUMMARY

This is a two-layer prosthesis that is used in all patients suffering from inguinal hernia.

The two layers, lower and upper, of which this dynamic prosthesis is composed, being each fixed on only one side opposite to that of the other, can move independently from each other.

All this avoids that during a muscular action (walking, coughing, ponzamento, etc.) traction and / or torsion points are formed, often responsible for immediate or distant post-operative aches and pains.

The lower layer creates a neo internal inguinal orifice and exerts a "sling" action on the spermatic cord. The latter takes on a "chicane" shape crossing the double prosthetic layer. The association of the "slingshot" with the "chicane" path of the funicular prevents recurrent external oblique hernias.

DESCRIPTION

The present invention relates to the proposal of a prosthesis for the treatment of an inguinal hernia with the following characteristics.

The dynamic prosthesis is a prosthetic complex consisting of two layers of non-absorbable or resorbable or mixed material that is applied to the floor of the inguinal canal as a treatment for a primary or recurrent inguinal hernia.

The two prosthetic layers are independent of each other or are fixed together along a line or in a single point.

By examining the operating methods, currently most performed all over the world, for the treatment of inguinal erection with the application of prostheses, we can identify two large groups of interventions:

I) those involving the suture of the prosthesis to the surrounding musculoaponeurotic structures, such as Γ Lichtenstein intervention (ftee tension); Π) those that involve the application of prostheses not fixed with sutures, such as Gilbert's surgery (sutureless).

The problems and limits of the method applied by Lichtenstein are represented by the excessive and misdistributed tension of the prosthesis which, being sutured on the perimeter, is unable to dynamically adapt to the modification of the relationships between the anatomical structures of the inguinal canal. This causes the onset of pain that the patient feels most frequently during movements involving the musculoaponeurotic structures of the inguinal region (coughing, bracing, transition from sitting to standing, etc.).

Furthermore, the suture itself is the cause of possible trauma, the consequences of which can lead to inconveniences or complications at a distance (lesions of vessels by stitch or traction, laceration of tissues, lesions of nerves).

The surgeon, who applies the aforementioned method, is faced with two types of problems: the first of cutting and packaging the prosthesis, which may be too large or too small, the second of positioning it in the inguinal region; in fact, a prosthesis that is too loose or too tense or with tensions not perfectly distributed can be responsible for complications and even persistent pains in the immediate and / or distant postoperative period.

In an attempt to overcome the drawbacks that the intervention with the perimeter suture of the prosthesis presents (Lichtenstein method), Gilbert was the first, and then other authors, decided to apply the mesh without fixing it with sutures, making it precede the insertion of a subfascial "plug" in the internal inguinal orifice (plug = a kind of plug in prosthetic material of various shapes and sizes inserted into the internal inguinal orifice to prevent the onset of an external oblique hernia).

The presence of this foreign body creates a series of drawbacks among which, by way of example, we can mention:

the perception of swelling in the inguinal area, linked to sclerosis stimulated by the presence of the plug, which the patient feels with relative discomfort;

the displacement of the plug itself which could lead to its contact with extraperitoneal organs (bladder, sigma, cecum) and be the cause of possible pressure ulcers on the same viscera;

the difficulty of treating a possible relapse in these conditions; the enormous difficulties of treating post-operative suppuration due to the presence of the subfascial plug which cannot be cleaned with a simple superficial dressing.

Furthermore, if we consider the spread of the hernia in the population, the routine use of the plug in the subfascial area, i.e. properitoneal, would expose a large number of patients to a risk of superinfection of the prosthesis if surgical intervention is necessary for a septic pathology. pelvic (colon tumors, appendicitis, prostate, bladder).

If the plug tends to displace itself already at the operating table, during coughing, the same authors, who emphasize its application, are forced to fix it with sutures, thus denying the principle of "sutureless".

Given that the passage from the supine to the upright position alone modifies the reciprocal relationships between the muscle-aponeurotic structures of the inguinal region, we recall that the mesh applied without suture in the suprafascial site in association with the plug, at a later time, can displace and assume a malposition compared to that made by the surgeon at the operating table. This increases the possibility of lifting the prosthesis especially at the suprapubic level, a complication confirmed by the frequency of relapses in this site even in operations in which the prosthesis is fixed with sutures.

And again, in the case of a non-anchored prosthesis, the fibroblastic reaction is delayed and hindered by the mobility of the mesh. Over time, the scar retraction acts further as a deforming element on the mesh itself.

Ultimately, if the application of a non-sutured mesh can find some justification in the case of an external oblique inguinal hernia not associated with the enlargement of the internal inguinal ring, in the case of a direct hernia the same method is impractical as regards the failure of the transversalis fascia is associated with the exhaustion of the external inguinal ring and the aponeurosis of the large oblique, sometimes reduced to a loose fibrous veil unsuitable for supporting the prosthesis under the pressure of abdominal pressure.

This explains why the same proponents of the method of applying the free prosthesis in some circumstances apply sutures; Gilbert, in fact, limits this method to cases in which the internal inguinal orifice is not exhausted and the floor of the inguinal canal is healthy.

To all this it should be added, in general, that, since there are no pre-packaged prostheses adaptable to all types of hernia, in many cases the prosthesis is cut out on the operating table by the surgeon himself to adapt it to different anatomical situations. If this adaptation procedure may seem a positive fact, vice versa it causes a series of problems listed below:

to cut out the prosthesis, the surgeon must interrupt an operation which extends its implementation times;

the cutouts and moldings made instantly by the surgeon on the prosthesis may fail in the best way due to various environmental factors (stress, distraction or a lack of "do-it-yourself" aptitude);

the waste of material due to the impossibility of reusing the scraps of the modeled nets, a fact that should not be underestimated given the high number of operations of this type performed in most operating theaters.

It is pointed out that there are too many elements of improvisation implicit in surgical procedures. In the end, the intervention carried out can be completely different from the one previously planned, according to little standardized methods and with too many variables entrusted to the surgeon's discretion.

The main purpose of the innovations which are the subject of the present invention is to eliminate the aforementioned drawbacks and to exploit in a rational way the use of the prosthesis in the surgical treatment of inguinal hernia.

A first characteristic of the invention consists in the creation of a prosthetic coupling aimed at avoiding the tractions and tensions inherent in a prosthesis fixed perimeter with sutures, allowing a free and autonomous movement of the two prosthetic components. This allows the invention to maintain the advantageous characteristics of the prostheses fixed on the entire perimeter and to overcome the limits of free prostheses.

A second feature of the invention consists in providing a prosthesis ready and suitable to be easily applied in all patients and in all cases of inguinal hernia, according to a planned method that leaves little room for improvisation and the surgeon's discretion.

A third feature is that it allows treatment of all inguinal hernias without going into a deep subfascial plane. The result is a more superficial treatment and therefore less traumatizing and minimally invasive also in function of a possible suppuration.

The invention will be illustrated with the aid of the attached tables where in Table I figure 1 represents the anatomical situation, figure 2 represents the lower prosthetic layer in one of the suggested preferential and non-binding forms, figure 3 represents the lower prosthetic layer positioned.

In Table II figure 1 represents the upper prosthetic layer in one of the suggested and non-binding preferential forms and figure 2 represents the prosthetic complex as a whole after the positioning of the upper layer.

In Table m section 1 illustrates the plane passing downstream of the internal inguinal orifice, section 2 the plane passing through the internal inguinal orifice and section 3 the plane passing upstream of the internal inguinal orifice.

Without prejudice to the idea of a solution, the invention is illustrated, with preferential but not limiting forms, in the attached tables. Table I in figure 1 shows the anatomical situation of the inguinal region once the hernia has been reduced and in which the following are shown:

a) the rectus abdominis muscle;

b) the lesser oblique and transverse muscles;

c) the spermatic cord protruding from the internal inguinal orifice; d) the anterior-superior iliac spine;

e) the aponeurosis of the external oblique muscle;

f) the inguinal ligament;

g) the floor of the inguinal canal covered by the transverse fascia; h) the tubercle of the pubis.

Figure 2 shows the lower prosthetic layer, preferably trapezoidal in shape, in which the "A-D" side, corresponding to the medial side, has an incision at the end of which an orifice (G) is modeled for the passage of the spermatic cord. The H-F side will be approached to touch the inguinal ligament (f) without being sutured to it. Consequently, the E-F side with respect to the "A-D" side will be oblique. But hypothetically any other conformation could be equally valid, if capable of obtaining the same desired effect.

The two medial offshoots A-B and C-D will be fixed autonomously with sutures to the sheath of the rectus abdominis muscle. This allows the movement of the net itself synchronous with the movements of the aforementioned muscle during coughing, ponzamento or in the efforts of the abdominal wall. All this without a variation of the tension on the sutures, and indeed accentuating the action of "sling" on the spermatic cord and strengthening the defense of the internal inguinal orifice.

Figure 3 shows the lower layer of the prosthesis positioned; offshoots A-B and C-D are fixed with sutures to the rectus muscle (a); the E-F side corresponds to the inguinal ligament (f) stretched between the pubis (h) and the anterior-superior iliac spine (d); the A-F side is located downstream of the internal inguinal orifice and the D-E side is located upstream of the same orifice. From the orifice (G), created in the lower layer of the prosthesis, the spermatic cord (c) emerges.

In Table Π in figure 4 we can see the upper prosthetic layer whose margin H-I will be fixed with sutures from the pubis until it widely exceeds the internal inguinal orifice according to an orientation that can be superimposed on that of the inguinal ligament, even if not binding and limiting. Q side H-I has a semilunar notch (L), also not limiting, which allows and facilitates the passage to the surface of the spermatic cord. This completes the "chicane" path of the spermatic cord between the two prosthetic layers.

The medial H-M margin of the upper prosthetic layer remains free and rests on the sheath of the rectus abdominis. Its rounded shape follows the line corresponding to the fusion of the aponeurosis of the external oblique on the sheath of the rectus abdominis muscles. The M-I margin will be free and located below the aponeurosis of the external oblique muscle, as seen in Figure 5.

Figure 5 shows the dynamic double-layer prosthesis as a whole. The upper layer is superimposed on the lower layer, shown positioned in Figure 3 (Figure 4). The latter has the H-I margin fixed to the inguinal ligament with detached or continuous sutures.

The crescent-shaped notch (L) supports and facilitates the passage and emergence of the spermatic cord (c). Once the aponeurosis of the external oblique muscle has been raised, the surgeon with a digital maneuver and without causing plication and twisting, extends the H-M margin of the upper prosthetic layer between the sheath of the rectus abdominis muscle (a) and the aponeurosis of the external oblique muscle. The latter will be placed on the prosthetic complex and sutured.

Table ΙΠ shows three sections of the inguinal region passing respectively downstream, at the level and upstream of the internal inguinal orifice.

Section 1, passing downstream of the internal inguinal orifice, demonstrates the aponeurosis of the external oblique muscle (e), the inguinal ligament (f), the transversalis fascia (g), the small oblique and transverse muscles (b) and the rectus abdominis (a).

The lower prosthetic layer (R) is sutured at point (S) to the sheath of the rectus abdominis (a). The upper prosthetic layer (T) is sutured at point (U) to the inguinal ligament (f).

Section 2, passing at the level of the internal inguinal orifice, demonstrates the "chicane" shape assumed by the spermatic cord (c) which becomes superficial by crossing the lower prosthetic layer (R) at the level of the orifice (G) and the upper one ( T) at the level of the notch (L).

Section 3 shows the two prosthetic layers (T) and (R) upstream of the internal inguinal orifice, equally fixed with sutures the superior (T) to the inguinal ligament (f), and the inferior (R) to the rectus abdominis muscle (a).

The invention described presents, in addition to the characteristics already mentioned, the innovative elements listed below:

it forces the spermatic cord to follow a "chicane" path which is accentuated during a muscular effort (coughing, bracing, walking, etc.), and prevents the onset of any external oblique recurrences;

the "sling" effect exerted by the lower prosthetic layer on the spermatic cord tends to mediate the spermatic cord and therefore to reduce the space between the cord itself and the medial margin of the internal inguinal orifice, quadrant in which recurrent oblique hernias occur external. The portion of the funiculus placed between the internal inguinal orifice and the notch (L) of the upper prosthetic layer is compressed between the floor of the inguinal canal, under the pressure of intra-abdominal pressure, and the prosthetic double layer. This involves a "sandwich" mechanism in which the spermatic cord itself acts as a closing and protective element for the internal inguinal orifice;

the lower prosthetic layer, being fixed only medially (side "A-D"), is only in that sense that it can move; when this occurs, the action of the "sling" on the spermatic cord is accentuated and the internal inguinal orifice is thus reduced;

the upper prosthetic layer, fixed only laterally to the inguinal ligament (margin H-I), is only in that sense that it can move, therefore in the opposite direction to that of the lower prosthetic layer. This implies: a) the reciprocal independence of the two prosthetic layers;

b) the complementary reinforcement action of the inguinal canal floor;

c) the absence of tension points on both prosthetic layers; d) adaptation to any conformation or change in tension of the abdominal wall, on the occasion of a muscular effort; e) the accentuation of the "chicane" of the spermatic cord; f) the further stabilizing action exerted by the portion of the funiculus placed between the two prosthetic layers which partially fixes the lateral sector (E-F) of the lower prosthetic layer; g) it is prevented from lifting the lateral margin of the lower prosthetic layer thanks to the funiculus that overlaps it and to the upper prosthetic layer that is fixed to the inguinal ligament in correspondence with the lateral margin; h) the impeded lifting of the medial margin of the upper prosthetic layer as it is placed between the sheath of the rectus abdominis and the aponeurosis of the external oblique which accentuate their grip during efforts;

i) the protective action that the lower prosthetic layer, fixed medially (latonA-D "), exerts on the medial sector of the upper prosthetic layer.

Claims (1)

CLAIMS 01) Dynamic prosthesis for the surgical treatment of all types of inguinal hernia characterized by being in two layers. 02) Dynamic prosthesis, according to the previous claim, shaped in such a way as to be ready and applicable in all cases of inguinal hernia. 03) Dynamic prosthesis, according to the preceding claims, characterized by two layers of resorbable or non-resorbable or mixed prosthetic material. 04) Dynamic prosthesis, according to the preceding claims, in which, preferentially but not limitingly, the perimeter of the two prosthetic layers or their entire surface or a part of this can be reinforced with the same or other material. 05) Dynamic prosthesis, according to the preceding claims, the lower layer of which, preferentially but not limitingly, is of a trapezoidal shape in order to effectively adapt to the reciprocal relationships between inguinal ligament, internal inguinal orifice and rectus abdominis muscle. 06) Dynamic prosthesis, according to the preceding claims, the lower layer of which has an orifice which allows the spermatic cord to pass through. 07) Dynamic prosthesis, according to the preceding claims, the upper layer of which has a shape that traces the surface included laterally by the inguinal ligament, medially by the fusion between the aponeurosis of the external oblique muscle and the rectus abdominis muscle and inferiorly by the pubis. As far as the superior margin is concerned ("Μ-Γ fig. 4), this largely exceeds the internal inguinal orifice in the direction of the anterior-superior iliac spine. 08) Dynamic prosthesis, according to the preceding claims, in which the lateral margin ("H-I" fig. 4) of the upper layer has a notch for the passage to the surface of the spermatic cord. 09) Dynamic prosthesis, according to the preceding claims, in which, even if only preferentially but not limitatively, the lateral margin ("H-I" fig. 4) has an orientation that can be superimposed on that of the inguinal ligament. 10) Dynamic prosthesis, according to the preceding claims, the shape of which allows its application on the suprafascial plane. This allows us to avoid any contact between the prosthetic material and the peritoneum. 11) Dynamic prosthesis, according to the preceding claims, in which the two prosthetic layers are fixed with sutures to the musculoaponeurotic structures of the inguinal canal, each on one side only and opposite to that of the other, in order to eliminate any possible tension and traction on the sutures. 12) Dynamic prosthesis, according to the preceding claims, which allows the independent movement of one layer with respect to the other. 13) Dynamic prosthesis, according to the preceding claims, in which the protective action of the inguinal canal is carried out by the two prosthetic layers in an associated and complementary manner. 14) Dynamic prosthesis, according to the preceding claims, in which the area protected by the complementary action of the two layers is variable in order to be able to adapt, in an optimal way, to the individual anatomical variations and to the modifications that occur in the same patient in relation to the change in decubitus and other muscular strains. 15) Dynamic prosthesis, according to the preceding claims, in which the lower prosthetic layer, being fixed with sutures only on the medial side, accentuates the sling mechanism on the spermatic cord during movements and muscular efforts. 16) Dynamic prosthesis, according to the previous claims, in which the two layers create a "chicane" of the spermatic cord, which is accentuated with muscular efforts, with the aim of enhancing the action of the sling and protecting the internal inguinal orifice and stabilization of the lateral portion of the lower prosthetic layer. 17) Dynamic prosthesis, according to the preceding claims, in which the medial margin of the lower layer ("A-D"), fixed with sutures, acts as a protective element of the free medial margin (H-I) of the upper layer. 18) Dynamic prosthesis, according to the preceding claims, in which the lateral margin of the upper layer (H-I) fixed with sutures, in conjunction with the action of the funiculus, acts as a protective element of the free lateral margin (E-F) of the layer inferior.